Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Vantage PSI System

K-Number: K193432 · 2020-11-09

Applicant3D Systems
Decision Date2020-11-09
Product CodeOYK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vantage PSI System is a medical device manufactured by 3D Systems. It received FDA 510(k) clearance on 2020-11-09 under approval number K193432. The device is classified under product code OYK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vantage PSI System?

Vantage PSI System is a medical device that received FDA 510(k) clearance on 2020-11-09. It is manufactured by 3D Systems. The 510(k) number is K193432.

When was Vantage PSI System approved by the FDA?

Vantage PSI System received FDA 510(k) clearance on 2020-11-09, under approval number K193432.

What company makes Vantage PSI System?

Vantage PSI System is manufactured by 3D Systems.

What is the FDA product code for Vantage PSI System?

The FDA product code for Vantage PSI System is OYK.

Related Clinical Trials

NCT06861309 Placental Imaging Techniques RECRUITING

Other Devices by 3D Systems

K192192VSP System K211244VSP® Orthopedics System K210347VSP System K214093VSP Bolus

Related Devices (Code: OYK)

K231585Vantage PSI System3D Systems, Inc. K223326Axiom PSR SystemRestor3D K243173Salto Talaris Ankle PSI System3D Systems, Inc. K243174Cadence Ankle PSI System3D Systems, Inc. K241148Salto Talaris Ankle PSI System3D Systems, Inc. K241326Cadence Ankle PSI System3D Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑